Federal Register / Vol. 89, No. 34 / Tuesday, February 20, 2024 / Notices 12845 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires Federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information 

Collection: Manufacturer Submission of 

Average Sales Price (ASP) Data for 

Medicare Part B Drugs and Biologicals; 

Use: Section 1847A of the Act requires 

that the Medicare Part B payment 

amounts for covered drugs and 

biologicals not paid on a cost or 

prospective payment basis be based 

upon manufacturers’ average sales price 

data submitted quarterly to the Centers 

for Medicare & Medicaid Services 

(CMS). The reporting requirements are 

specified in 42 CFR part 414 subpart J. 

CMS, specifically, the Division of 

Data Analysis and Market-based Pricing 

(DDAMBP) will utilize the ASP data 

(ASP and number of units sold as 

specific in section 1847A of the Act) to 

determine the Medicare Part B drug 

payment amounts for CY 2005 and 

beyond. The manufacturers submit their 

ASP data for all of their National Drug 

Codes (NDC) for Part B drugs. DDAMBP 

compiles the data, analyzes the data and 

runs the data through software to 

calculate the volume-weighted ASP for 

all of the NDCs that are grouped within 

a given HCPCS code. The formula to 

calculate the volume-weighted ASP is 

the Sum (ASP * units) for all NDCs/Sum 

(units * bill units per pkg) for all NDCs. 

DDAMBP provides ASP payment 

amounts for several components within 

CMS that utilize 1847(A) payment 

methodologies to implement various 

payment policies including, but not 

limited to, ESRD, OPPS, OTP and 

payment models. CMS will also use 

reported ASP and units to calculate 

inflation adjusted coinsurance and 

rebates. The Department of Health and 

Human Services’ Office of the Inspector 

General also uses the ASP data in 

conducting studies. Form Number: 

CMS–10110 (OMB Control Number: 

0938–0921); Frequency: Quarterly; 

Affected Public: Private and Business or 

other for-profits; Number of 

Respondents: 500; Number of 

Responses: 2,00; Total Annual Hours: 

26,000. (For policy questions regarding 

this collection contact Felicia Brown at 

(410) 786–9287 or Felicia.brown@

cms.hhs.gov). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–03348 Filed 2–16–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10466] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by March 21, 2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Patient 

Protection and Affordable Care Act; 

Exchange Functions: Eligibility for 

Exemptions; Use: The data collection 

and reporting requirements in ‘‘Patient 

Protection and Affordable Care Act; 

Exchange Functions: Eligibility for 

Exemptions; Miscellaneous Minimum 

Essential Coverage Provisions’’ (78 FR 

39494 (July 1, 2013)), address Federal 

requirements that states must meet with 

regard to the Exchange minimum 

function of performing eligibility 

determinations and issuing certificates 

of exemption from the shared 

responsibility payment. In the final 

regulation, CMS addresses standards 

related to eligibility, including the 

verification and eligibility 

determination process, eligibility 

redeterminations, options for states to 

rely on HHS to make eligibility 

determinations for certificates of 

exemption, and reporting. CMS 

developed four appendices of 


ddrumheller on DSK120RN23PROD with NOTICES1
12846 Federal Register / Vol. 89, No. 34 / Tuesday, February 20, 2024 / Notices 

application materials to illustrate the 

process applicants use to apply for 

exemptions from the shared 

responsibility payment. This 

information collection requests seeks 

approval for the requirements associated 

with the collection of information 

associated with these four appendices. 

No comments were received in response 

to the 60-day comment period. Form 

Number: CMS–10466 (OMB control 

number 0938–1190); Frequency: 

Annually; Affected Public: Individuals 

and Households—State, Local, or Tribal 

Governments; Number of Respondents: 

849; Total Annual Responses: 849; Total 

Annual Hours: 1,962. (For policy 

questions regarding this collection 

contact John Kenna at 301–492–4452.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–03363 Filed 2–16–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10662 and CMS– 

10219] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by March 21, 2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Administrative 

Simplification HIPAA Compliance 

Review; Use: Section 1173 of the Social 

Security Act (the Act), 42 U.S.C. 1320d– 

2, and section 264 of HIPAA require the 

Secretary to adopt a number of national 

standards to facilitate the exchange of 

certain health information and to 

protect the privacy and security of such 

information. 

The Secretary promulgated rules that 

relate to compliance with, and 

enforcement of, the HIPAA rules, which 

are codified at 45 CFR part 160, subparts 

C, D, and E and collectively referred to 

as the Enforcement Rule. The Secretary 

first issued an interim final rule 

promulgating the procedural 

requirements for imposition of civil 

money penalties on violations of the 

privacy standards on April 17, 2003, 

Civil Money Penalties: Procedures for 

Investigations, Imposition of Penalties 

(68 FR 18896). The Secretary 

subsequently proposed a rule on April 

18, 2005, HIPAA Administrative 

Simplification: Enforcement; Proposed 

Rule (70 FR 20224), proposing the 

amendment of 45 CFR part 160, 

subparts A (General Provisions), C 

(Compliance and Enforcement), and E 

(Procedures for Hearing), and proposing 

a new subpart D (Imposition of Civil 

Money Penalties) that addressed the 

substantive issues related to the 

imposition of civil money penalties and 

proposing the above provisions be 

applied to all HIPAA rules. 

The purpose of this collection is to 

retrieve information necessary to 

conduct a compliance review and carry 

out the authority delegated to CMS as 

described in CMS–0014–N (68 FR 

60694). These forms will be submitted 

to the Centers for Medicare & Medicaid 

Services (CMS), National Standards 

Group, from entities covered by HIPAA 

Administrative Simplification 

regulations. This collection is not 

applicable to HIPAA Privacy and 

Security Rules. Form Number: CMS– 

10662 (OMB Control Number: 0938– 

1390); Frequency: Weekly; Affected 

Public: Private, State, Local, or Tribal 

Governments, Federal Government, 

Business or other for-profits, Not-forprofits institutions; Number of 

Respondents: 50; Total Annual 

Responses: 50; Total Annual Hours: 

500. (For policy questions regarding this 

collection contact Kevin Stewart at (410) 

786–6149.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: HEDIS Data 

Collection for Medicare Advantage; Use: 

Sections 422.152 and 422.516 of title 42 

of the Code of Federal Regulations (CFR) 

specify that MAOs must submit quality 

performance measures as specified by 

the Secretary of the Department of 

Health and Human Services and by 

CMS. These quality performance 

measures include HEDIS®. HEDIS® 

data are used in the Medicare Part C 

Star Ratings which are used to 

determine Quality Bonus Payments to 

Medicare Advantage contracts. 


ddrumheller on DSK120RN23PROD with NOTICES1